Investigate Effect of AMG 151 on 24-hour Ambulatory Blood Pressure & Glucose Levels in Type 2 Diabetes Mellitus Subjects

Phase 1

Terminated

• Conditions: Diabetes Mellitus
• Interventions: Drug: AMG 151; Other: Placebo

• Registration Number: NCT01755442
• Lead Sponsor: Amgen

Brief Summary

This is a phase 1, randomized, double-blind, placebo-controlled, 2-way crossover study to evaluate the effect of AMG 151 on 24-hour ambulatory blood pressure and glucose levels in subjects with type 2 diabetes mellitus who are on a stable regimen of metformin alone, metformin and a dipeptidyl peptidase-4 inhibitor (DPP4), metformin and a thiazolidinedione (TZD), or metformin, a DPP4, and a TZD for a minimum of 3 months prior to randomization.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-27
• Study First Submitted QC: 2012-12-19
• Study First Posted: 2012-12-24
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-19
• Last Update Posted: 2013-04-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AMG 151	AMG 151	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Mean 24-hour systolic blood pressure	After 14 days of AMG 151 or placebo treatment

Secondary Outcome Measures

Name	Time	Method
4-hour concentration time profile of glucose after the mixed meal tolerance test	After 13 days of AMG 151 or placebo treatment
Plasma glucose 2 hours after time 0 of mixed meal tolerance test	After 13 days of AMG 151 or placebo treatment
Mean 24-hour heart rate	After 14 days of AMG 151 or placebo treatment
Mean 24-hour diastolic blood pressure	After 14 days of AMG 151 or placebo treatment
24-hour concentration time profile of glucose level from continuous glucose monitoring	Day 1 and day 14 of each period
Fasting plasma glucose and fructosamine	After 13 days of AMG 151 or placebo treatment
Safety end points will include the incidence of treatment emergent adverse events.	Up to 2 Months
Serum AMG 151 concentration	Up to 2 Months
Safety end points will include laboratory safety tests.	Up to 2 Months.
Safety end points will include vital signs.	Up to 2 Months
Safety end points will include ECGs.	Up to 2 Months

Trial Locations

Locations (1)

Research Site; 🇺🇸 San Diego, California, United States